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Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction (STIM-ALC)

Primary Purpose

Alcohol Withdrawal

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active rTMS
Sham rTMS
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Withdrawal focused on measuring alcool, rTMS, executive, dysfunction, addiction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18-75 years
  • Alcohol use disorder according to DSM 5, moderate to mild according to ADS
  • Residential stay for alcohol detoxofication

Exclusion Criteria:

  • Cognitive deficits defined by MoCA <25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation
  • History of cerebral stroke
  • DSM-5 substance use disorders other than nicotine and alcohol

  • Contraindication for rTMS :

    • Pregnancy
    • History of epilepsy or seizure
    • Cochlear implants
    • Cardiac pacemaker or intracardiac lines, or metal in the body
  • Clinical history of complicated withdrawal symptoms
  • History of severe head trauma followed by loss of consciousness
  • Actual major depressive episode, schizophrenia according to the MINI (Mini International Neuropsychiatric Interview)
  • Breastfeeding women
  • Actual or history of organic failure including cirrhosis
  • Absence of health insurance; or patient with AME
  • Legal protection (curatorship or tutorship)
  • Deprive of freedom or security measure
  • No adequate mastering of the French language or no ability to consent
  • Major socio-economic problem: homelessness
  • No written informed consent
  • Participation in another interventional study

Secondary inclusion criteria (before randomization):

- Abnormal executive function defined as at least 3 impaired measurements among 19 measurements of 7 tests (Stroop test, Wisconsin test; Trail making test, verbal fluency, 6 elements, Brixton test, Dual task Baddeley test) from the Greffex battery. Each measure will be considered as impaired if it is below 1.65 SD. The procedure and the measurement are standardized. The neuropsychological evaluation will be performed at least seven days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation.

Sites / Locations

  • Hôpital Universitaire Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

Bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC

Sham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC

Outcomes

Primary Outcome Measures

Percentage of participants with continuous complete alcohol abstinence
Percentage of patients with continuous complete abstinence up to one month after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-Time Line Follow Back tool (TLFB). The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record at M1 the number of days they drank over the 30 days following the end of the rTMS treatment. Continuous complete abstinence will be defined as no day with alcohol consumption over the 30 days.

Secondary Outcome Measures

Percentage of participants with alcohol continuous complete abstinence
Percentage of patients with continuous complete abstinence up to 3 months after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-TLFB at M1, M2, M3. Continuous complete abstinence will be defined as no day with alcohol consumption over the 90 days.
Number of cumulative abstinence days
Alcohol consumption measured by the number of cumulative abstinence days up to 1 month after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days when no alcohol was consumed over the 30 days.
Number of cumulative abstinence days
Alcohol consumption measured by the number of cumulative abstinence days up to 3 months after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days when no alcohol was consumed over the 90 days.
Time until the first heavy drinking days (HDD)
Time until the first heavy drinking days (HDD) up to 3 months. The time, in days, until the first HDD will be assessed using (TLFB) at M1, M2, M3. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Number of heavy drinking days (HDD)
Number of heavy drinking days (HDD) up to 1 month. Number of heavy drinking days HDD will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days with HDD over the 30 days. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Number of heavy drinking days (HDD)
Number of heavy drinking days (HDD) up to 3 months. Number of heavy drinking days HDD will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days with HDD over the 90 days.. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time to relapse
The time to relapse, in days, will be assessed using (TLFB) at M1, M2, M3. Relapse will be defined as a day with a consumption equal or higher than 50% of initial intake.
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS)
Change in cue induced craving Visual Analogic Scale (VAS) from baseline to the last rTMS session. Cue induced craving VAS will be measured after alcohol cues viewing at baseline and then daily on the morning just before rTMS sessions. The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Alcohol cue induced craving using a Visual Analogic Scale (VAS)
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Alcohol due induced craving using a Visual Analogic Scale (VAS)
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Number of impaired measures on the Grefex batery (executive functions)
Executive performance will be evaluated by the number of impaired measures on the Grefex battery : Stroop test, Wisconsin Test, Trail Making Test, verbal fluency, 6 elements, Brixton test and Dual task Baddeley test. Upon these 7 tests, 19 index will be measured (number of errors, time to make the task .). Each measure will be considered as impaired if it is below 1.65 SD. Number of impaired measures will be recorded for each patient.
Stroop test
Stroop test will be performed 1 month after the end of the rTMS sessions. The stroop test assess the cognitive inhibition. Time and number of non-corrected errors will be reported for each conditions 1) denomination 2) reading 3) interference.
Trail making test
Trail making test will be performed 1 month after the end of the rTMS sessions. The trail making test assess the mental flexibility. Time and number of errors will be reported for the trail making test A and the trail making test B. For this last condition, the number of perserverations will be also reported.
Verbal fluency
Verbal fluency will be performed 1 month after the ned of the rTMS sessions. The verbal fluency assess the lexical generation ability. The number of words produced will be reported.
Wisconsin Test
Wisconsin test will be performed 1 month after the ned of the rTMS sessions. The Wisconsin test assess the ability of deduction and rules maintenance. Number of correct categories, number of errors and number of perseverations will be reported.
Brixton test
Brixton test test will be performed 1 month after the ned of the rTMS sessions. The Brixton test assess the deduction abilify of working rules. Number of errors will be reported.
6 elements
6 elements test will be performed 1 month after the ned of the rTMS sessions. The 6 elements test assess the planning and organization ability of the behavior. Ranking score will be reported.
Dual task Baddeley test
Dual task Baddeley testwill be performed 1 month after the end of the rTMS sessions. The Dual task Baddeley assess the working memory. Mu index will be reported.
Quality of life assessed by the Quality of life Scale (AQoLS)
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
Quality of life assessed by the Quality of life Scale (AQoLS)
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
% rTMS stimulation performed with optimal stimulation parameters
Achievement of optimal stimulation parameters will be assessed for each patient by the percentage of sessions performed with the theoretical threshold (110%).
Percentage of rTMS sessions performed.
Treatment compliance will be assessed by the percentage of rTMS sessions performed.
Percentage of participants experiencing sides effect
rTMS security will be assessed by the percentage of patients experiencing sides effects during the study and their nature: seizure induction, transient acute hypomania induction, syncope, transient headache, local pain, neck pain, toothache, paresthesia, transient hearing changes, other.

Full Information

First Posted
July 31, 2021
Last Updated
August 27, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04997330
Brief Title
Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
Acronym
STIM-ALC
Official Title
Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.
Detailed Description
PARTICIPANTS: Participants with AUD (moderate to mild according to Alcohol Dependance Scale) with executive dysfunctions will be randomized. DESIGN: This study is a multicenter pilot double blind randomized controlled trial. After at least seven days of alcohol residential detoxification, executive dysfunctions's participants will be tested. 64 of them with executive dysfunctions will be randomized either in the active rTMS group or in the sham rTMS group. TMS will be performed during hospitalisation over 10 days. rTMS are proposed as an add on to the usual treatment. INTERVENTION: 20 rTMS (twice a day) will be performed 10 consecutive working days. The target of the rTMS will be the DLPFC (left side in the morning, right side in the afternoon). During each rTMS sessions (active and sham), alcohol related pictures from the Geneva Appetitive alcohol Pictures will be presented.In the active arm, rTMS will be performed with high frequency (20hz, 1500 pulses per session, 110% of motor threshold).In the control group, sham rTMS will be performed. Participants will be follow up to three months after the end of rTMS treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal
Keywords
alcool, rTMS, executive, dysfunction, addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Arm Title
Sham rTMS
Arm Type
Placebo Comparator
Arm Description
Sham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Intervention Type
Device
Intervention Name(s)
Active rTMS
Other Intervention Name(s)
Experimental group
Intervention Description
Bilateral high frequency (20Hz) rTMS will be delivered (over dorsolateral prefrontal cortex), at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive days on working day, 1500 pulses/session, 110% of motor threshold determined, 30 trains, 50 pulses per train and 15s inter train. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Control group
Intervention Description
Sham rTMS will be delivered (over dorsolateral prefrontal cortex) , at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive working days. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
Primary Outcome Measure Information:
Title
Percentage of participants with continuous complete alcohol abstinence
Description
Percentage of patients with continuous complete abstinence up to one month after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-Time Line Follow Back tool (TLFB). The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record at M1 the number of days they drank over the 30 days following the end of the rTMS treatment. Continuous complete abstinence will be defined as no day with alcohol consumption over the 30 days.
Time Frame
1 month after the end of rTMS sessions
Secondary Outcome Measure Information:
Title
Percentage of participants with alcohol continuous complete abstinence
Description
Percentage of patients with continuous complete abstinence up to 3 months after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-TLFB at M1, M2, M3. Continuous complete abstinence will be defined as no day with alcohol consumption over the 90 days.
Time Frame
3 months after the end of rTMS sessions
Title
Number of cumulative abstinence days
Description
Alcohol consumption measured by the number of cumulative abstinence days up to 1 month after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days when no alcohol was consumed over the 30 days.
Time Frame
1 month after the end of rTMS sessions
Title
Number of cumulative abstinence days
Description
Alcohol consumption measured by the number of cumulative abstinence days up to 3 months after the end of the rTMS treatment. The number of cumulative abstinence days will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days when no alcohol was consumed over the 90 days.
Time Frame
3 months after the end of rTMS sessions
Title
Time until the first heavy drinking days (HDD)
Description
Time until the first heavy drinking days (HDD) up to 3 months. The time, in days, until the first HDD will be assessed using (TLFB) at M1, M2, M3. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time Frame
3 months after the end of rTMS sessions
Title
Number of heavy drinking days (HDD)
Description
Number of heavy drinking days (HDD) up to 1 month. Number of heavy drinking days HDD will be assessed using (TLFB) at M1 and will be calculated by summing the total number of days with HDD over the 30 days. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time Frame
1 month after the end of rTMS sessions
Title
Number of heavy drinking days (HDD)
Description
Number of heavy drinking days (HDD) up to 3 months. Number of heavy drinking days HDD will be assessed using (TLFB) at M1, M2, M3 and will be calculated by summing the total number of days with HDD over the 90 days.. HDD will be defined as more than 50 (men) or 40 (women) g/day.
Time Frame
3 month after the end of rTMS sessions
Title
Time to relapse
Description
The time to relapse, in days, will be assessed using (TLFB) at M1, M2, M3. Relapse will be defined as a day with a consumption equal or higher than 50% of initial intake.
Time Frame
3 months after the end of rTMS sessions
Title
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Description
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Time Frame
1 month after the end of rTMS sessions
Title
Alcohol dependence severity assessed by the Alcohol Dependence Scale (ADS)
Description
Alcohol dependence severity will be evaluated with the Alcohol Dependence Scale (ADS). The ADS is a self-administrated 25-items questionnaire (requiring 5 minutes) assessing alcohol withdrawal symptoms, impaired control over drinking, awareness of compulsive drink, increased tolerance and salience of drink-seeking behavior. ADS is initially used to assess a past 12-month period, its instructions can be modified for different time-frame. The ADS will be assessed on previous 4 weeks. This scale is scored out of 47, higher scores are considered worse.
Time Frame
3 months after the end of rTMS sessions
Title
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Description
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time Frame
At the last day of rTMS sessions
Title
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Description
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time Frame
at 1 month after the end of rTMS sessions
Title
Alcohol cue induced craving using the Cue induced Obsessive Compulsive Drinking Scale (OCDS)
Description
Evaluated by Cue induced Obsessive Compulsive Drinking Scale (OCDS). Cue induced OCDS will be measured after alcohol cues viewing. French version of OCDS is a self-administrated 14-items instrument assessing obsessive and compulsive characteristics of drinking-related thoughts, urge to drink or craving, and ability to resist those thoughts and urges. This scale is scored out of 56, higher scores are considered worse. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures . The same diaporama will be used for all visits in all centers.
Time Frame
at 3 months after the end of rTMS sessions
Title
Change in Alcohol cue induced craving using a Visual Analogic Scale (VAS)
Description
Change in cue induced craving Visual Analogic Scale (VAS) from baseline to the last rTMS session. Cue induced craving VAS will be measured after alcohol cues viewing at baseline and then daily on the morning just before rTMS sessions. The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time Frame
From baseline to the last rTMS session after the end of rTMS sessions
Title
Alcohol cue induced craving using a Visual Analogic Scale (VAS)
Description
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time Frame
At 1 month after the end of rTMS sessions
Title
Alcohol due induced craving using a Visual Analogic Scale (VAS)
Description
The VAS is scored out of 10, higher scores are considered worse. Alcohol cues will be the same as for OCDS.
Time Frame
At 3 months after the end of rTMS sessions
Title
Number of impaired measures on the Grefex batery (executive functions)
Description
Executive performance will be evaluated by the number of impaired measures on the Grefex battery : Stroop test, Wisconsin Test, Trail Making Test, verbal fluency, 6 elements, Brixton test and Dual task Baddeley test. Upon these 7 tests, 19 index will be measured (number of errors, time to make the task .). Each measure will be considered as impaired if it is below 1.65 SD. Number of impaired measures will be recorded for each patient.
Time Frame
1 month after the end of rTMS sessions
Title
Stroop test
Description
Stroop test will be performed 1 month after the end of the rTMS sessions. The stroop test assess the cognitive inhibition. Time and number of non-corrected errors will be reported for each conditions 1) denomination 2) reading 3) interference.
Time Frame
1 month after the end of rTMS sessions
Title
Trail making test
Description
Trail making test will be performed 1 month after the end of the rTMS sessions. The trail making test assess the mental flexibility. Time and number of errors will be reported for the trail making test A and the trail making test B. For this last condition, the number of perserverations will be also reported.
Time Frame
1 month after the end of rTMS sessions
Title
Verbal fluency
Description
Verbal fluency will be performed 1 month after the ned of the rTMS sessions. The verbal fluency assess the lexical generation ability. The number of words produced will be reported.
Time Frame
1 month after the end of rTMS sessions
Title
Wisconsin Test
Description
Wisconsin test will be performed 1 month after the ned of the rTMS sessions. The Wisconsin test assess the ability of deduction and rules maintenance. Number of correct categories, number of errors and number of perseverations will be reported.
Time Frame
1 month after the end of rTMS sessions
Title
Brixton test
Description
Brixton test test will be performed 1 month after the ned of the rTMS sessions. The Brixton test assess the deduction abilify of working rules. Number of errors will be reported.
Time Frame
1 month after the end of rTMS sessions
Title
6 elements
Description
6 elements test will be performed 1 month after the ned of the rTMS sessions. The 6 elements test assess the planning and organization ability of the behavior. Ranking score will be reported.
Time Frame
1 month after the end of rTMS sessions
Title
Dual task Baddeley test
Description
Dual task Baddeley testwill be performed 1 month after the end of the rTMS sessions. The Dual task Baddeley assess the working memory. Mu index will be reported.
Time Frame
1 month after the end of rTMS sessions
Title
Quality of life assessed by the Quality of life Scale (AQoLS)
Description
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
Time Frame
At 1 month after the end of rTMS sessions
Title
Quality of life assessed by the Quality of life Scale (AQoLS)
Description
Quality of life will be evaluated with Alcohol Quality of Life Scale (AQoLS) French version. This scale is a self-administrated 34-item questionnaire measuring health-related quality of life. The questionnaire explores 7 domains, i.e. activities, relationships, self-esteem, negative emotions, living conditions, control and sleep. The total score was obtained by summing all items, and the theoretical range was therefore 0-102; higher scores are considered better.
Time Frame
At 3 months after the end of rTMS sessions
Title
% rTMS stimulation performed with optimal stimulation parameters
Description
Achievement of optimal stimulation parameters will be assessed for each patient by the percentage of sessions performed with the theoretical threshold (110%).
Time Frame
At the end of rTMS treatment
Title
Percentage of rTMS sessions performed.
Description
Treatment compliance will be assessed by the percentage of rTMS sessions performed.
Time Frame
At the end of rTMS treatment
Title
Percentage of participants experiencing sides effect
Description
rTMS security will be assessed by the percentage of patients experiencing sides effects during the study and their nature: seizure induction, transient acute hypomania induction, syncope, transient headache, local pain, neck pain, toothache, paresthesia, transient hearing changes, other.
Time Frame
3 months at the end of rTMS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-75 years Alcohol use disorder according to DSM 5, moderate to mild according to ADS Residential stay for alcohol detoxofication Exclusion Criteria: Cognitive deficits defined by MoCA <25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation History of cerebral stroke DSM-5 substance use disorders other than nicotine and alcohol Contraindication for rTMS : Pregnancy History of epilepsy or seizure Cochlear implants Cardiac pacemaker or intracardiac lines, or metal in the body Clinical history of complicated withdrawal symptoms History of severe head trauma followed by loss of consciousness Actual major depressive episode, schizophrenia according to the MINI (Mini International Neuropsychiatric Interview) Breastfeeding women Actual or history of organic failure including cirrhosis Absence of health insurance; or patient with AME Legal protection (curatorship or tutorship) Deprive of freedom or security measure No adequate mastering of the French language or no ability to consent Major socio-economic problem: homelessness No written informed consent Participation in another interventional study Secondary inclusion criteria (before randomization): - Abnormal executive function defined as at least 3 impaired measurements among 19 measurements of 7 tests (Stroop test, Wisconsin test; Trail making test, verbal fluency, 6 elements, Brixton test, Dual task Baddeley test) from the Greffex battery. Each measure will be considered as impaired if it is below 1.65 SD. The procedure and the measurement are standardized. The neuropsychological evaluation will be performed at least seven days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fanny LEVY, Docteur
Phone
01.42.16.28.94
Email
fanny.levy@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Romain ICICK, Docteur
Phone
01 40 05 48 69
Email
romain.icick@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny LEVY, Docteur
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Universitaire Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Radenne
Phone
01 42 16 16 99
Email
anne.radenne@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
IPD Sharing Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal

Learn more about this trial

Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction

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